Research Information System
Jornal de Pediatria, vol.101, no.6, 2025 (SCI-Expanded, Scopus)
Objective: Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe cutaneous adverse drug reactions, particularly concerning in pediatric populations due to their unique etiologies, clinical outcomes, and long-term complications. This study aims to examine pediatric cases of SJS/TEN reported in the U.S. FDA's FAERS database, focusing on age-stratified patterns and drug associations. Method: A retrospective cross-sectional analysis was conducted using FAERS reports submitted until the end of 2024. Pediatric cases (0–17 years) with a diagnosis of SJS or TEN and a single suspected drug were included. Reports were analyzed by age group (0–11 and 12–17 years), gender, and drug classification using ATC codes. Statistical analyses assessed associations between demographic groups and implicated medications. Results: Out of 2673 pediatric reports, 67.4 % involved SJS and 32.6 % TEN. The majority (62.3 %) were in the 0–11 age group. Nervous system agents—especially antiepileptics—were predominantly associated with older children, while systemic antiinfectives such as amoxicillin, azithromycin, and cefaclor were more frequent in younger children. Lamotrigine showed both age groups and female predominance. Conversely, paracetamol and ibuprofen were significantly associated with the TEN phenotypes in younger males. Conclusions: The study reveals clear age- and drug-specific patterns in pediatric SJS/TEN. Findings emphasize the importance of age-stratified pharmacovigilance issues and cautious prescribing of high-risk drugs such as lamotrigine and antibiotics. Better awareness of potential biases, such as protopathic misattribution, is crucial for accurate signal detection in pediatric pharmacovigilance.